NEW DRUGS INTRODUCTION IN VIETNAM – SHORT
PROGRESS UPDATE
Manila, Dec.2014
Summary
 Process and activities done by steps acording to implementation
plan
 Challenges and obstacles encountered
BDQ introduction/ Implementation
plan
 Step 1. Country’s readiness assessment
 Step 2. Identification of partners involved (MOH, KNCV, WHO,




NI&ADR centers, CHAI)
Step 3. Establishment of National Task Force and BDQ technical
working group
Step 4: Development of national treatment plan for introduction of
BDQ
Step 5: Bedaquiline implementation
Step 6: Generating evidence for scale up
Step 1. country’s readiness assessment-Done
Country level
Ha Noi
Ho Chi
Minh
Can Tho
Laboratory capacity
x
x
x
x
Clinical Review Committee
X (Nat, Tx Unit)
x
x
x
Case management
x
x
x
x
Recording & reporting
x
x
x
x
Monitoring & Evaluation
X (periodically, all
levels, checklist)
x
x
x
Pharmacovigilance
x
x
x
x
Technical assistance
X
x
x
x
DRS
X (4 times)
x
x
x
Budget
X (GF)
x
x
x
Drug supply system
x
x
x
x
Reporting and recording
 Papers based R-R according to WHO’s report forms
 Electronic reporting system
 VITIMES (DS-TB)
 e-TB manager (DR-TB): has piloted in HCM City and
expanded (at district level in HCMC and provincial
level in other PMDT provinces)
PV methods in NTP
Since 2013
Cohort
Event Monitoring
Spontaneous
reporting
Since 1994
CEM in MDR-TB treatment
Study B6.1: AEs of anti-TB drugs in the treatment of MDR-TB in Vietnam.
 Timeline:
2014
Activities
2015
2016
2013
1 2 3 4 5 6 7 8 9 101112 1 2 3 4 5 6 7 8 9 101112 1 2 3 4 5 6 7 8 9 101112
Protocol and tools
Protocol approval
Training
Enrolment
Data collection, data input
& patient management
Data analysis
Report
End up
Now
Surveillance and
supporting
Step 2-3 (Done)
 Step 2. Identification of partners involved (MOH,
KNCV, WHO, NI&ADR centers, CHAI)
 Step 3. Establishment of :
 National Task Force (Vice Minister, representatives of MOH related
departments, NTP)
 BDQ technical working group
Step 4: Development of national treatment plan for
introduction of BDQ-Done
 Selection of pilot sites (Hanoi, HCMC, Can Tho)
 Update the treatment guidelines and training materials
 Timeline development
 Budget: GF approval for the first 100 patients in 2015
Update treatment guideline
 Target group for BDQ introduction
 FQ resistance in MDR-TB patients
 Second line injectable resistance in MDR-TB patients
 XDR-TB patients
 Others:


Intolerate with SLDs in standard cat 4 regimen
Resistant to at least 2 group 4 drugs (Cs,Pto/Eto,PAS)
 Use on top of treatment regiment per WHO
guidelines (companion handbook 2014)
Timeline development
Actitities
TWG meeting
Task Force meeting
Implementation plan
Submission to MOH for approval
Drugs order
Update the treatment guidelines and training
materials
Training for pilot sites
Update e-TB manager for BDQ
Dev. Of R-R and PV for BDQ
Budget
Patients screening for treatment
Treatment initiation
TA Supervision
Q1
2014
X
Q2
2014
X
Q3
2014
X
X
X
X
Q1
2015
X
X
X
X
X
Q2 2015
onwards
X
X
X
X
X
Q4
2014
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
BDQ introduction process-Activities
done

April 2013: 1st introduction workshop of new TB drug Bedaquiline (WHO – Viet Nam MOH – NTP)

February 2014: 2nd workshop about BDQ (WHO – MOH – NTP): country’s readiness assessment for BDQ
implementing

April 2014: establishment and 1st meeting of Vietnam BDQ technical working group, 1st draft of National
Implementation plan

June 2014: Global Fund approved budget for treatment with BDQ for the first 100 patients

June 2014: 1st draft of Clinical guidelines of using BDQ in MDR/pre-XDR and XDR-TB treatment

July 2014: MOH officially established the National Task force for implementing new TB drug (heading by Vice
Minister and representatives from related departments of MOH, NTP)

August 2014: NTP in collaboration with Pharmacovigilance dept. of Hanoi Pharmacy University to prepare the
CEM for ADRs of BDQ (B5.16)

September 2014: 3rd meeting of BDQ TWG: revise and finalize required document.

November 2014:
 Join the meeting on preparing for the introduction of new TB drugs & Inter-regional workshop on PV
 1st Task Force meeting: ways to prepare supporting documents to submit for approval
Step 5: Bedaquiline implementation
 Hold advocacy and initiation workshops in 3 pilot provinces
among NTP – Provincial People Committee – Department of
health – Provincial TB hospital (Dec 2014)
 Preparing 3 pilot sites: materials, equipment and trainings
(patient screening, clinical management, active
pharmacovigilance …- Jan 2015)
 Place the order of drugs (Jan 2015)
 Patient screening and initiation: 1st patient enrolled in BDQ
treatment (2nd Q/2015)
 Monitoring treatment response
 Detection, management and reporting of adverse events
Step 6: Generating evidence for
scale up
 Minimum basic data set (compared with control groups)
 Adverse events (harms) in individuals exposed to new drug
 % of patients treated with bedaquiline who experienced severe adverse events (heart,
liver)
 % of patients whose regimen need to be changed due to AE
 Response to treatment (effectiveness)
 % of success rate
 Time to culture convertion
 % of patients who resistant to bedaquiline
 Adhearance to treatment:
 % Default
 % interrupt using BDQ during 6 months
 Patient’s experience of using BDQ
 KEY DATA FOR ASSESSMENT OF Bedaquiline IMPLEMENTATION (No screened,
eligible, enrolled, Tx outcome, etc)
Advantages
 Strong commitment of NTP leaders and pilot sites in BDQ
implementation in Vietnam. Establishment of National TF with
representatives from MOH (powerful advocacy)
• Great technical support from partners, especially WHO (both head
quarter and country office): experts, technical documents
• Budget for 1st 100 patients (including drugs, examinations and PV) has
already been approved by the Global Fund
• Good collaboration with HN Pharmacy university in implementing
pharmacovigilance activities for BDQ in the same time (also funded by the
GF)
Main challenges
• BDQ is still in the phase III clinical trial  May delay in
administrative procedures  require stronger advocacy
effort
• GF mainly supports drugs and examinations, still lack of
funding for program cost and health system cost
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